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Driven.
For Quality. -
Samsung Biologics is committed to upholding the highest quality standards by ensuring that all CGxP processes comply with global regulatory guidelines and industry expectations.
Quality System
With a centralized and unified Quality team, we take end-to-end responsibility for quality across all of our facilities.
Our comprehensive Quality System is enhanced by digitalization, enabling proactive quality management. We have an established training program, which guarantees that any personnel involved in CGMP operations are qualified to do so.
Our comprehensive Quality System is enhanced by digitalization, enabling proactive quality management. We have an established training program, which guarantees that any personnel involved in CGMP operations are qualified to do so.
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EQUIS
Enterprise Quality Unified
Information System -
Electronic Quality Management System (eQMS) encompassing quality event management, change control and documentation management
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LMS
Learning
Management System -
Management system for employee training, certification, and personal qualification
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LIMS
Laboratory Information
Management System -
Integrated system for 24/7 management of laboratory data and QC testing activities
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Quality Culture
The Quality Unit functions independently from Operations to ensure that all CGMP processes comply with regulatory guidelines and industry expectations. The team is structured across Quality Control (QC), which ensures rigorous analytical testing and compliance, and Quality Assurance (QA), which oversees process integrity and regulatory standards. Along with a dedicated Regulatory Affairs team, we ensure the quality, safety, and efficacy of your products from development to IND/IMPDs, BLA/MAAs, and beyond.
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- Quality Control
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- Testing Operations
- Method Transfer & Optimization
- Facility Monitoring
- Sample Management
- Stability Programs
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- Quality Assurance
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- Facility Oversight
- Training & Quality Systems
- Analytical & Development Oversight
- Audit & Inspection Management
- Data Governance
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- Regulatory Affairs
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- Preparation of Common Technical Document
- Response to Questions
- Regulatory Strategy & Consulting
- Regulatory Intelligence
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- 0
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Regulatory approvals
(FDA, EMA, PMDA, etc.)
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- 99%
- Batch Success Rate